CRC Sabah Newsletter Issue 2 a.pdf

7/27/2019 CRC Sabah Newsletter Issue 2 a.pdf

1/12

The CRC Sabah Newsletter is a joint publication of the three CRC networks in

Sabah which comprise CRC HQE, CRC HQE 2, and CRC Likas. The newslet-

ter will update you with the activities organized by the CRCs, the upcoming

events, and the research updates.

In this issue, we are delighted to announce the upcoming inaugural Sabah

Medical Research and Scientific Conference 2013 that will take place in the

Postgraduate Medical Centre (PGMC), Queen Elizabeth Hospital, Kota Kina-

balu, Sabah on 18th and 19th October 2013. The highlight of the event is the

poster/oral competition which will be the platform to all healthcare profes-

sionals and students to share their research works with their peers. For those

who participate in this event, we would like to wish you the best of luck and

see you there soon!

WELCOME TO ISSUE 2 OF CRC

SABAH NEWSLETTER

CRCs Objectives are:

1.To promote a culture ofresearch among healthcareworkers in Sabah.

2.To disseminate skills inMethodology, Statisticaltools, and techniques indesigning and conducting

clinical trials.

3.To provide healthcareworkers the principle ofmethodology and biostatis-tics in clinical research.

CRC SABAH Issue 2

May - August 2013

CRCs Vision

To be a leading clinical research institution in Asia

CRCs Mission

To improve patients health outcomes through ethical and quality clinicalresearch

Inside this issue:

Page

Welcome to Issue 2 of CRCSabah Newsletter

1

Investigator Initiated Research

(IIR) and Industry Sponsored

Research (ISR) Updates

2

Activities and Photo Gallery 6

RCC Progress Report 8

Contact Us 10

Upcoming Events 10


2/12

CRC Sabah NewsletterIssue 2 (May-Aug 2013)

No. NMRR ID Study Title Study Site1 NMRR-12-1183-14034

Sequence Variants of Putave Tumor Suppressor Genes in Nasopharyngeal

CarcinomaQEH

2 NMRR-12-1105-13079 Molecular Phylogenec Analysis of Malaria Parasite Plasmodium knowlesi JKNS

3

NMRR-13

-217

-15663

Research on Asian Psychotropic Prescripon Paerns for Andepressants

Follow up survey in 2013

HMBP

4 NMRR-12-1324-13746 Malaysian Acromegaly Registry QEH

5 NMRR-12-1175-13912The Funconal Improvement Aer Carpal Tunnel Release Using the Mini

Open Technique in Hospital Queen Elizabeth IIQEH 2

6 NMRR-13-196-15238Awareness and Atudes Towards HPV Vaccine and HPV-Related Diseases

Among HPV Vaccine Seekers in Keningau Hospital, SabahKeningau Hospital

7 NMRR-13-291-15704A Case Control Study on Environmental and Host-Related Factors Predis-

posing to Tuberculosis in Kota KinabaluQEH

8 NMRR-13-285-15720Clinical Presentaon of Leptospirosis. A Retrospecve Study of Paents

Admied to a Single Instuon Lahad Datu Hospital, SabahLahad Datu Hospital

9 NMRR-13-155-15167Are We Ready Ror the Early Discharge of People With Mental Illness Into

the Community?HMBP

10 NMRR-13-332-15632Development of Novel Biomarkers and Assessment of Health

-Related Qual-

ity of Life in Malaysian Paents With Nasopharyngeal CarcinomaQEH

11 NMRR-13-332-15632Development of Novel Biomarkers and Assessment of Health-Related Qual-

ity of Life in Malaysian Paents With Nasopharyngeal CarcinomaQEH

12 NMRR-12-1135-12252

A prospecve, Proof-of-concept Study to Evaluate High on-Clopidogrel

Platelet Reacvity and its Role in Determining Treatment Strategy,

Amongst Paents Presenng With Acute Coronary Syndromes or Undergo-

ing Percutaneous Coronary Intervenon

QEH 2

13 NMRR-13-241-15699Sokongan Sosial Kepada Pesakit Yang Menghidapi "terminal illness" dan

Mendapat Penjagaan Paliaf: Kajian Kes di Hospital Queen ElizabethQEH

14 NMRR-13-429-14814Deliberate Self-Poisoning and Self-Injury Cases in Duchess of Kent Hospital,

SandakanHDOK

15 NMRR-13-410-15337

An Evaluaon of Inial Vancomycin Dosing Based on Measured Serum

Trough Concentraon in Paediatric Paents in SWACH: A Retrospecve

Review

HWKKS

16 NMRR-13-404-15569

Inuence of Age, Gender, Ethnicity and Distance of Hospital From Home

Towards Time in Therapeucs Range (TTR) Among Warfarin MTAC Paents

in Hospital Tawau

Tawau Hospital

17 NMRR-13-234-15329Prevalence and Idencaon of Plasmodium knowlesi in Humans, Ma-

caques and Mosquitoes at Sabah, Malaysia

QEH / Tenom

Hospital

18 NMRR-13-308-14792

The Development and Tesng of a Model of Community Based Collabora-

ve Care for Paents With Severe and Enduring Mental Disorders in Malay-

sia: Phase 1.

HMBP

19 NMRR-13-590-15718 Database Registry of Children With Tuberous Sclerosis Complex HWKKS

20

NMRR-12

-1377

-14445

Muldisciplinary Approach in Improving Health Outcomes of Psoriasis Pa-

ents

QEH

21 NMRR-13-126-15119Prevenon of Post-ERCP Pancreas: A Randomized Clinical Trial using

Rectal DiclofenacQEH

22 NMRR-13-247-14802Validaon of the Malay version of the Strengths and Dicules Queson-

naire (SDQ) for the Malaysian PopulaonHMBP

23 NMRR-13-534-16348Kajian Kepenggunaan Portal MyHEALTH Dalam Kalangan Pesakit Hospital

Kementerian Kesihatan Malaysia 2013JKNS

24 NMRR-13-425-14815Substance Use Among Psychiatric npaents in Duchess of Kent Hospital,

SandakanHDOK

25 NMRR-13-354-16253 Amalan Gaya Hidup Sihat di Kalangan Paramedik Hospital Kuala Penyu Kuala Penyu Hospital

26 NMRR-13-546-16814Atude and Percepons of Healthcare Professionals towards Clinical Phar-

macy Services in Lahad Datu Hospital

Lahad Datu Hospital

Table 1: Investigator Initiated Research (IIR) approved by MREC


3/12


Table 2: Ongoing Industry Sponsored Research (ISR) in Sabah. May-Aug 2013.

No. NMRR_IDDepartment/

Unit

Site

InstuonResearch Title

Research

Subtype

1NMRR-10-

706-6055 Endocrine QEH I

A Phase III, mulcentre, internaonal, randomised,

parallel group, double blind cardiovascular safety

study of BI 10773 (10 mg and 25 mg administered

orally once daily) compared to usual care in type 2

diabetes mellitus paents with increased cardiovas-

cular risk.

Intervenonal

Study : ClinicalTrial

2NMRR-10-

628-5357Nephrology QEH I

Phase IIb/III Clinical Study Protocol

- Chronic Renal Failure (Primary Glomerular Dis-

ease/Nephrosclerosis) -

Intervenonal

Study : Clinical

Trial

3NMRR-12-

426-11014Rheumatology QEH I

A Phase 3b, Mulcenter, Open-Label Study to Evalu-

ate the Long-Term Safety and Ecacy of Subcutane-

ous LY2127399 in Paents with Systemic Lupus Ery-

thematosus (SLE) (ILLUMINATE-X)

Intervenonal

Study : Clinical

Trial

4 NMRR-

12-

1071-13841 Rheumatology QEH I

A Randomized, Double-Blind, Placebo-Controlled 52-

Week Study to Assess Adverse Events of Special

Interest in Adults with Acve, Autoanbody-

PosiveSystemic Lupus Erythematosus Receiving

Belimumab

Observaonal

Study : ClinicalEconomics

5NMRR-09-


A Mulcenter, Randomized, Double-blind, Placebo-

controlled Trial of Golimumab, an An-TNF Mono-

clonal Anbody, Administered Intravenously, in

Subjects with Acve Rheumatoid Arthris Despite

Methotrexate Therapy

Intervenonal

Study : Clinical

Trial

6NMRR-10-


An observaonal study of Rheumatoid arthris pa-

ents on adalimumab to Evaluate quality of LIfe

Variables, Eects on work producvity and funcon-

al outcomes in Malaysia

Observaonal

Study : Clinical

Economics

7NMRR-10-


A Phase 3, Mulcenter, Randomized, Double-

Blind,Placebo-Controlled Study to Evaluate the Ecacy

and Safety of Subcutaneous LY2127399 in Paents

with Systemic Lupus Erythematosus (SLE)

IntervenonalStudy : Clinical

Trial

8NMRR-10-


A randomized, double-blind, parallel-group study of

safety and the eect on clinical outcome of tocili-

zumab SC versus placebo SC in combinaon with

tradional disease modifying an-rheumac drugs

(DMARDs) in paents with moderate to severe ac-

ve rheumatoid arthris

Intervenonal

Study : Clinical

Trial

9NMRR-09-


A Long-Term, Open-Label Follow-Up Study of Tofa-

cinib (CP-690,550) For Treatment of Rheumatoid

Arthris. Protocol No. A3921024

Intervenonal

Study : Clinical

Trial

10NMRR-11-

865-9930Pathology QEH I

Scienc Partnership for HER2 Tesng Excellence

(SPHERE) Clinical Audit

ObservaonalStudy : Paent

registry/Clinical

database

11NMRR-11-

800-10093Hematology/

ENT/ OncologyQEH I/

HWKKS

Cancer and Its Economic Impact on Household in the

ASEAN Countries HOUSEHOLD IN THE (ACTION

Study)

Observaonal

12*NMRR-13-

127-14699Oncology HWKKS

A three-arm, randomized, open label, phase II study

of everolimus in combinaon with exemestane ver-

sus everolimus alone versus capecitabine in the

treatment of postmenopausal women with estrogen

receptor posive, locally advanced, recurrent, or

metastac breast cancer aer recurrence or pro-

gression on prior letrozole or anastrozole

Intervenonal

Study : Clinical

Trial


4/12


No NMRR_IDDepartment/

Unit

Site

InstuonResearch Title

Research

Subtype

13NMRR-12-900-

13137Hematology QEH I

A Randomized, Open-label, mulcenter study to eval-

uate paent preference with subcutaneous admin-

istraon of Rituximab versus intravenous Rituximab in

previously untreated paents with CD20+ diuse

large B-Cell Lymphoma or CD20+ Follicular Non-

Hodgkin's Lymphoma grade 1,2 or 3a

Intervenon-

al Study :

Clinical Trial

14NMRR-12-181-

10976

Gastroenterol-

ogyQEH I

A Mul-centre, Randomised, Double

-blind, Placebo

-

controlled Trial to Determine the Ecacy and Safety

of Hepar-P Capsule for the Treatment of Non-

Alcoholic Fay Liver Disease (NAFLD)

Intervenon-

al Study :

Clinical Trial

15NMRR-11-1010-

10697

Gastroenterol-

ogyQEH I

A Phase 3, Safety and Ecacy Study of Boceprevi-

r/Peginterferon Alfa-2a/ribavirin in Chronic HCV Gen-

otype 1 IL28B CC Subjects

Intervenon-

al Study :

Clinical Trial

16NMRR-12-493-

11112Respiratory QEH I

A randomized, double-blind, double-dummy, 4-week

treatment, parallel-group study to evaluate the eca-

cy and safety of two doses of mometasonefuroate

delivered via Concept1 or Twisthaler in adult and

adolescent paents with persistent asthma

Intervenon-

al Study :

Clinical Trial

17NMRR-10-198-

5403Cardiology QEH 2

ProspeCve observaonal LongitudinAlRegIstryoF

paents with stable coronary arterY disease

Observaon-

al Study :

Paent reg-

istry/Clinical

database

18NMRR-12-690-


Asian Sudden Cardiac Death in Heart Failure (ASIAN-

HF) Prospecve Observaonal Registry

Observaon-

al Study :

Clinical Epi-

demiology

19NMRR-08-1443-


Heart Outcomes Prevenon Evaluaon

(HOPE)-3

Observaon-

al Study

20*NMRR-12-715-


A Double-blind, Randomized, Placebo

-controlled,

Mulcenter Study Assessing the Impact of Addional

LDL-Cholesterol Reducon on Major Cardiovascular

Events When AMG 145 is Used in Combinaon With

Stan Therapy In Paents with Clinically Evident Car-

diovascular Disease

Intervenon-

al Study :

Clinical Trial

21*NMRR-12-

1102-13587Cardiology QEH 2

A Randomized, Double-Blind, Placebo-Controlled,

Parallel-Group Study to Evaluate the Eect of

SAR236553/REGN727 on the ocurrence of Cardiovas-

cular Events in Paents Who Have Recently Experi-

enced an Acute Coronary Syndrome

Intervenon-

al Study :

Clinical Trial

22NMRR-10-753-

6795Psychiatrics HMBP

A Randomized, Double-blind, Placebo-Controlled,

Parallel-Group Study of PaliperidonePalmitate Evalu-

ang Time to Relapse in Subjects With SchizoaecveDisorder

Intervenon-

al Study :

Clinical Trial

23

*NMRR-12-826-

13119 Psychiatrics HMBPA Phase 3, Mulcentre, Randomized, Double-blind,

Placebo-controlled Trial to Evaluvate the Ecacy,

Safety, and Tolerability of Brexpiprazole(OPC-34712)

as Maintenance Treatment in Adults with Schizophre-

nia

Intervenon-

al Study :

Clinical Trial

24NMRR-09-654-

4406Oncology HWKKS

A Randomized, Mulcenter, Open-Label, Phase 3

Study to Compare the Ecacy and Safety of Pani-

tumumab and Cetuximab in Subjects with Previously

Treated, Wild-Type KRAS, Metastac Colorectal Can-

cer

Intervenon-

al Study :

Clinical Trial


5/12


No NMRR_ID Department/Unit SiteInstuon Research Title ResearchSubtype

25NMRR-11-395-

9024Oncology HWKKS

A Open-Label Study of Abiraterone Acetate in Sub-

jects with Metastac Castraon-Resistant Prostate

Cancer Who Have Progressed Aer Taxane-Based

Chemotherapy

Intervenon-

al Study :

Clinical Trial

26NMRR-11-991-

9842 Oncology HWKKS

A Randomized, Double-blind, Placebo-controlled

Study to Evaluate the Long-term Safety and Ecacy

of Darbepoen Alfa Administered at 500 g Once-

Every-3-Weeks in Anemic Subjects With Advanced

Stage Non-small Cell Lung Cancer Receiving Mul-

cycle Chemotherapy

Intervenon-

al Study :Clinical Trial

27NMRR-11-1020-

10569Oncology HWKKS

A phase II prospecve, two-cohort non-randomized,

mulnaonal, open label study to assess the safety of

assisted-and self-administered subcutaneous

Trastuzumab as therapy in paent with operable

HER2-posive early breast cancer

Intervenon-

al Study :

Clinical Trial

28NMRR-12-50-

10793

Paediatric

(Infecous

Disease)

HWKKS

A hospital-based, retrospecve study of the burden of

community acquired pneumonia in children aged


6/12

Page 6 Volume 1 , I ssue 1


7/12

Newslet ter Ti t le Page 7

Table 3: Summary of ISR Status in Sabah. 2008 - 2013.

ISR Status Total

ISR CompletedISR OngoingSR UpcomingISR Terminated

3535911

Total 90


8/12


NEW CRC HQE2 ROOM, 28th JUNE 2013

R E S E A R C H P R O T O C O L D E V E L O P M E N T W O R K S H O P , H Q E 2 , 1 8 - 1 9 T H M A Y 2 0 1 3

THERMO GUARD INSTALLATION & TRAINING, HQE2, 4th JULY 2013Thermoguardis a system for automac central

temperature monitoring. It is an industry standard for

online temperature and humidity control via a computer

network. In CRC, Thermoguardhas been used to monitor

refrigerators that store the Invesgaonal Product (IP) in

which the temperature needs to be maintained at a

certain level. The system comprises intelligent sensor

controllers with a network connecon, temperature

sensor connected to the network and the Thermoguard

soware.

VISIT AND MEETING FROM CRM OFFICER, 8-9th JULY 2013

Page 6


9/12

CRC Sabah NewsletterIssue 2 (May-Aug 2013) Page 9

Site Initiation Visit ODYSSEY, HQE2 17th JULY 2013

RESEARCH AWARENESS DAY , HOSPITAL KENINGAU, 27th JULY 2013

Workshop on Basic Medical Biostatistics Using SPSS, SPU UMS, 27-28th Aug 2013

CRC Sabah Network Meeting, CRC HQE, 15th August 2013


10/12

Page 8CRC Sabah NewsletterIssue 2 (May-Aug 2013)

Clinical Research Centre Sabah, Hospital Queen Elizabeth (CRC,HQE) has developed a

standard operating procedure for the research consultation clinic. It started the first formalresearch consultation clinic on 1 April 2013.

39.3%(11 out of 28) of them were specialists from various departments. It was followed bypharmacists (25%) and medical officers (21.4%). Other categories of researchers who did cometo the research consultation clinic were science officers, medical lab technologists and dieticians.

PRO GRESS REPO RT O F RESEARC H CONSULTATION C L INIC (RCC)

Since the setting up of the research clinic, the response has been quite good. We recorded the

highest number of researchers in July 2013 (15 clients with 9 new appointments). The ratio of

new appointments and follow up appointments in a month was 1:2. The cumulative number of

clients up to the end of Aug 2013 was 28 with 45 appointments.


11/12


Most of them were at the protocol development stage at the first consultation. About two thirds(67.8%, 19 researchers) came at the early stage of their research (ranging from literature searchto protocol review). 25% of them came for help in the data entry and analysis.

Page 11

About 35.7% of them were still in the protocol development stage at the end of August 2013.25%were at the process of data involvement either collection or analysis of the data. 7 of them (25%)have finished their research and had been writing their reports (2) or presented their researchresults at a conference (5).

0

1

2

3

4

5

No

type

Type of first consultation

10

5

4

3 3

2

0

2

4

6

8

10

12

No

Outcome

Research outcome


12/12


Contact UsClinical Research Centre

Hospital Queen Elizabeth

Locked Bag No 2029

88586 Kota Kinabalu

Sabah

Tel: 088-517507

Fax: 088-211906

Email: [email protected]

Clinical Research Centre

Level 5, Cardiology Clinic

Hospital Queen Elizabeth IILorong Bersatu

Off Jalan Damai Luyang

88300 Kota Kinabalu

Sabah

Tel: 088-324600 (2019)

Fax: 088-272454

Clinical Research Centre

Hospital Wanita Dan Kanak-Kanak(Hospital Likas)

Karung Berkunci No 187

88996 Kota Kinabalu

Sabah

Tel : 088-522600

Upcoming Events1. Inaugural Sabah Medical Research and Scienc Conference In Conjuncon With Sabah

Research Day 2013

Date : 18-19 October 2013 ( PGMC, Hospital Queen Elizabeth)

Research Consultation ClinicProvide consultation services to facilitate

researchers in:

1. Research ideas

Literature Search

2. Research proposals Study design

Sample size calculation

Statistical analysis

3. Data analysis

4. Presentation / publication

Consulting services are provided at the CRC unit.

An appointment is required, and may be made

by email or by phone:[email protected],

[email protected]

Tel: 088-517507 or 088-324600 ext 2019).

TENTATIVE CONFERENCE PROGRAMPRE-CONFERENCE WORKSHOP18th October 2013 (Friday)

8.00 am 11.45 amMAIN CONFERENCE DAY 118th October 2013 (Friday)8.00 am 5.00 pmMAIN CONFERENCE DAY 219th October 2013 (Saturday)

7.30 am 5.00 pm

Good Clinical Practice Refresher Workshop Opening ceremony by Deputy Director General of Health, Ministry of Health Malaysia Keynote lecture 1 & 2

Keynote lecture 3, 4, 5 & 6 Oral Presentation Competition 1 & 2 Sessions Announcement of winners and prize giving ceremony

2. Intermediate Biostascs Workshop

Date: 28-30 October 2013

Venue: Sekolah Perubatan (SPU), UMS

Day Venue Time

Monday CRC, HQE 8.00am-12.00 noon2.30pm-4.30pm

Tuesday CRC, HQE 2(Level 5, Cardiology Clinic)

8.00am-12.00 noon2.30pm-4.30pm

Page 10

Documents

CRC Sabah Newsletter Issue 2 a.pdf